This content is current only at the time of printing. This document was printed on 24 March 2017. A current copy is located at http://apvma.gov.au/node/131
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The APVMA can take a range of enforcement actions to ensure compliance, including giving a formal warning, issuing an infringement notice, issuing an enforceable direction, issuing a substantiation notice, entering into an enforceable undertaking, varying conditions placed on an authorisation (permit, approval, licence), suspending or cancelling an authorisation, and issuing a notice to stop supply or recall products.
Formal warnings about an activity, enforceable directions, enforceable undertakings and infringement notices (fines) are all mechanisms that allow us to provide a proportional and rapid response to certain situations or incidences of noncompliance. Because each noncompliant action or behaviour is unique, our response will vary. We are not obliged to use any particular option.
The APVMA may issue a formal warning where reasonable grounds exist to suspect that conduct contravenes or has contravened agvet legislation.
A formal warning places a person or business on notice that we have identified noncompliance issues of concern. The warning gives them an opportunity to address the problem, but also warns them that stronger enforcement action may be taken if the noncompliance is not rectified or recurs.
The APVMA has developed a regulatory guideline (Compliance and enforcement—formal warnings) to explain how we may use this power.
An enforceable undertaking is a legally enforceable agreement to act, or refrain from acting, in a particular manner, in order to become compliant with the Admin Act, Code Act or Collection Act. Enforceable undertakings can only be agreed with a person whose activity is regulated by those Acts. They cannot be imposed on anyone who does not have compliance obligations under the legislation. Enforceable undertakings provide an opportunity for the regulated entity to be involved in the resolution of a matter without the need to formally address the noncompliance through the courts.
The APVMA has developed a regulatory guideline (Compliance and enforcement—enforceable undertakings) to explain how we may use these powers.
Orders to enforce an enforceable undertaking
If the APVMA considers that any term of an undertaking has been breached, then it can apply to the court for an order that includes any or all of the following:
- directing the person to comply with the undertaking
- directing the person to pay the Commonwealth an amount up to the amount of any financial benefit reasonably attributable to the breach of the undertaking
- directing the person to compensate any other person who has suffered loss or damage as a result of the breach
- any other order the court considers appropriate.
Infringement notices (fines) may be issued by an APVMA inspector when they have reasonable grounds to believe that a prescribed civil penalty provision of the agvet legislation has been breached in the previous 12 months.
The inspector can issue an infringement notice for contraventions of certain civil penalty provisions. In issuing the notice, we are alleging that the contravention has occurred. If the recipient of the notice pays the specified penalty, their liability for the alleged contravention is discharged. If the penalty is not paid, the matter will go to court. On our application, the court will determine whether the alleged offence or contravention has been established.
Penalty infringements are an efficient and effective way to address noncompliance and provide a viable alternative to court proceedings. The monetary values of infringements are prescribed by regulation and must not exceed 1/5th of the maximum penalty that could be imposed by a Court. Payment of an infringement notice acquits the matter and no conviction is recorded. Payment of an Infringement Notice is not an admission of guilt.
We do not issue an infringement without first having sufficient evidence to produce a comprehensive brief of evidence, in the event that court proceedings become necessary. A recipient of an Infringement Notice has the right to apply for extensions to pay, make written representations to the APVMA seeking withdrawal of the notice or choose not to pay the prescribed amount. We will initiate court proceedings as necessary to support any issued infringement notice, including disputes by the recipient of a notice or a failure to discharge any financial liability.
We have developed a regulatory guideline (Compliance and enforcement—infringement notices) to explain how we may use the power to issue an infringement notice.
Suspension and cancellation of authorisations
The APVMA issues a range of authorisations, including manufacturing licences, permits, consents to import and approvals of products and active constituents. We are empowered to suspend or cancel an authorisation in response to noncompliance with the authorisation.
The Code Act allows us to suspend or cancel any market authorisation we provided, such as active constituent approval, a product registration or a permit. These response options are valuable and viable components of compliance and enforcement activities. They are also integral to the operation of the chemical reconsideration (commonly called ‘chemical review’) and permit assessment.
When issuing a restriction of market authorisation, the APVMA considers the need for a related recall notice or permit. As a minimum, any restriction on market authorisation prohibits further entry of material into the supply chain. Limited permits addressing material already in the supply chain or in current use are considered on a case-by-case basis. When we restrict market authorisation based on imminent risk to public health, we do not facilitate the continued supply or use of the chemical (which would continue the risk) but work to withdraw the product from the market.
In determining the need for action, we consider the public exposure to the active constituent or product and the likelihood of harm to people, animals, the environment or international trade. We also consider the legislated obligation of industry to provide information to us, comply with the conditions, and conform to assessed criteria as detailed in section 41 of the Code Act.
The Code Act provides that we may suspend a market authorisation in instances of:
- imminent risk to persons of death, serious injury or serious illness
- breaching a condition of approval or registration
- failing to give information, samples or results of trials or experiments when we ask for them
- providing false or misleading information to support, or in connection with, an approval or registration
- arbitration on compensation for use of protected information is unsuccessful
- chemical reconsideration decisions
- noncompliance with criteria for approval or registration.
When the grounds for suspension relate to failing to provide required information we must revoke the suspension once compliance with requirements has been established. In other cases, we may revoke the suspension.
As part of the suspension, we may consider the future cancellation of the market authorisation. All provisions in the Code Act that provide for a suspension are extended to grounds for cancellation. We are not obliged to suspend a product before cancellation. When we believe it necessary, we can cancel a market authorisation. In determining the need for action, we consider the public exposure to the active constituent or product, the likelihood of harm to people, animals, the environment or international trade.
We have developed a regulatory guideline (Compliance and enforcement—non-compliance related suspension or cancellation of authorisations) to explain how we may use these powers.